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China grants EUA to Covid-19 vaccine against XBB descendent lineages

Pharmaceutical Technology

5+delta) protein vaccine (Sf9 cell). The subunit antigen in the vaccine has been based on the structure of the targeting S-RBD and HR proteins of the XBB and BA.5 It is self-assembled into stable trimeric protein particles with the addition of squalene-based oil-in-water emulsion adjuvant following purification and mixing.

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FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

Pharmaceutical Technology

The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen.

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Datroway’s Approval in Breast Cancer Solidifies Daiichi Sankyo’s Leadership in ADCs

XTalks

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. months for Datroway and 18.3 months for chemotherapy.

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ARVINAS AND PFIZER ANNOUNCE GLOBAL COLLABORATION TO DEVELOP AND COMMERCIALIZE PROTAC® PROTEIN DEGRADER ARV-471

The Pharma Data

(NYSE: PFE) today announced a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. Despite advancements in oncology in recent years, considerable unmet need persists in the treatment of HR+ breast cancer.

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Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer

The Pharma Data

1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease. 6 Currently chemotherapy remains the only treatment option for patients with HR-positive tumours following progression on endocrine (hormone) therapy. 7 Few targeted options are available for those who are HR-negative.

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VIKTORIA-1: A Clinical Trial For Patients With Breast Cancer

Trialfacts

VIKTORIA-1 is a clinical trial aimed at evaluating gedatolisib, a new investigational drug for patients with HR+/HER2-, Stage 3 or 4 breast cancer. This trial explores the potential of gedatolisib, given intravenously, to inhibit the PI3K/mTOR pathway, which is known to regulate cell growth and function.

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Phase 2 FIGHT Trial Results Presented at ASCO GI Validate Importance of FGFR2b Overexpression and Reinforce Potential of Bemarituzumab Plus Chemotherapy as a Frontline Targeted Treatment for FGFR2b+ Gastric and GEJ Cancers

The Pharma Data

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Phase 2 FIGHT Trial: Summary of Efficacy*. HR (95% CI): 0.68.

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